IPP Placement & Intracavernosal Block (IPP)

Randomized Controlled Trial of Intracorporal Local Anesthesia vs Saline Prior to Placement of Inflatable Penile Prosthesis Placement

The inflatable penile prosthesis (IPP) is the gold standard for surgical management of erectile dysfunction (ED) and there is no consensus on the best postoperative pain management regimen. In the wake of the opioid epidemic, postoperative pain management is heavily scrutinized. The National Institute of Health estimated over 81,000 individuals died following overdose of any opioids in 2022 alone; of these, over 14,000 deaths were linked to prescription opioids. Thus, strategies to minimize postoperative pain should not only improve patient experience but also lessen the need to escalate to opioid usage.

Study Overview

• Status: Not yet recruiting
• Conditions: Erectile Dysfunction (ED)
• Intervention / Treatment: Drug: Exparel/bupivacaine mixture

Detailed Description

It would be ideal to create an effective and easily reproducible approach to pain prevention and pain management in men undergoing IPP placement. One highly appealing target would be intracavernosal administration, as there would be no ambiguity regarding delivery of agent at the time of surgery. Thus far, no prospective randomized controlled trials have explored the efficacy of intracavernosal administration of local anesthetic for pain management.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sachin Vyas; Phone Number: 336.713.4098; Email: Sachin.Vyas@Advocatehealth.org
• Study Contact Backup: Name: Kimberly Waggener, MD; Phone Number: 336.713.4098; Email: kimberly.waggener@advocatehealth.org

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
      • Contact: Sachin Vyas; Phone Number: 336-713-4098; Email: Sachin.Vyas@Advocatehealth.org
      • Contact: Kimberly Waggener, MD; Phone Number: 336.713.4098; Email: kimberly.waggener@advocatehealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Any patient undergoing primary three-piece inflatable penile prosthesis (IPP) placement at Lexington Medical Center

Exclusion Criteria:

• Patients undergoing revision and/or secondary IPP placement
• Patients taking prescribed narcotic medications at the time of IPP surgery
• Patients undergoing concomitant Peyronie's Disease surgery (modeling, plication, grafting) at the time of IPP surgery
• Patients with liver and/or renal disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Saline Arm; 10cc of normal saline will be injected into each corporal body (left and right for a total of 20cc)
Experimental: Exparel/bupivacaine mixture Arm; 10cc Exparel/bupivacaine mixture will be injected into each corporal body (left and right for a total of 20cc)	Drug: Exparel/bupivacaine mixture; 10cc of Exparel (133 mg, 1.3%) with 10cc of 0.5% standard bupivacaine (50 mg )for total volume of 20cc into the corpora immediately prior to placement of corporotomy stay sutures.; Other Names: Exparel (133 mg, 1.3%) with 10cc of 0.5% standard bupivacaine (50 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS) Scores	VAS scores range from 0 to 100, with 0 representing no pain or the least desirable state and 100 representing the worst possible pain or the most desirable state. The "score" is the distance in millimeters from the "no pain" end of the 100mm line to the point where the person marks their pain level. Lower scores (0-4mm) indicate no pain, while higher scores (75-100mm) indicate severe pain.	Hour 1
Visual Analogue Scale (VAS) Scores	VAS scores range from 0 to 100, with 0 representing no pain or the least desirable state and 100 representing the worst possible pain or the most desirable state. The "score" is the distance in millimeters from the "no pain" end of the 100mm line to the point where the person marks their pain level. Lower scores (0-4mm) indicate no pain, while higher scores (75-100mm) indicate severe pain.	Hour 4
Visual Analogue Scale (VAS) Scores	VAS scores range from 0 to 100, with 0 representing no pain or the least desirable state and 100 representing the worst possible pain or the most desirable state. The "score" is the distance in millimeters from the "no pain" end of the 100mm line to the point where the person marks their pain level. Lower scores (0-4mm) indicate no pain, while higher scores (75-100mm) indicate severe pain.	Hour 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Morphine milligram equivalents (MME)	Cumulative morphine milligram equivalent (MME) is a metric used by healthcare providers to standardize the total potency of all opioid medications a patient is taking. By converting each opioid into a standard value based on morphine, providers can assess a patient's overall risk for overdose and other complications. Higher cumulative MME levels are associated with a greater risk of overdose. For example, doses of 50 MME or more per day increase overdose risk and warrant closer monitoring, while doses of 90 MME or more are considered very high.	Day 2
Number of calls, messages, or visits to clinic	Physician access line calls, messages to clinic, visits to clinic for postoperative pain within 30 days after surgery	Day 30
Number of Complications	Complications from intracavernosal injections	Day 30
Number of Other Complications	Other complications after IPP surgery using the Clavien-Dindo grading scale - The Clavien-Dindo scale is a grading system that categorizes surgical complications based on the treatment required to manage them, providing a uniform and objective way to assess and report post-operative events. It consists of five grades, with Grade I being minor deviations not requiring intervention and Grade V indicating patient death	Day 30
Serum bupivacaine levels	Serum bupivacaine levels at 1 hour and 1 day after surgery - Serum bupivacaine levels are a measurement of the drug in the blood, and the "normal" or safe level varies significantly by the patient's condition, the administration site, and the dose - A 1-mL serum or plasma sample is typically collected in a red-top or green-top tube	Hours 1 and 24
Amount of tramadol usage	Use the lowest dose possible for the shortest time needed. Take your prescribed dose as indicated by your healthcare provider. The maximum dosage is 1 or 2 tablets every 4 to 6 hours, as needed for pain relief.	Hour 24

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Ryan Terlecki, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Pain management; inflatable penile prosthesis (IPP); Penile pain
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Neurobehavioral Manifestations; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Erectile Dysfunction; Agnosia
• Other Study ID Numbers: IRB00129597

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the Individual participant data collected during the trial, after deidentification
• IPD Sharing Time Frame: Immediately following publication - no end date
• IPD Sharing Access Criteria: anyone who wishes to access the data
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No